CTRI/2025/11/097555尚未招募Unknown
A Prospective Post-Market Clinical Follow-up Study to Evaluate the Safety and Performance of Polyether Ether Ketone Carbon Fibre (PEEK CF) Interference Screws in Knee Arthroscopy Patients
Auxein Medical Pvt Ltd2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
This is a multi-centric prospective PMCF study. The study aims to assess safety and performance of PEEK CF interference screws used in ACL and PCL reconstruction. A total of 40 patients will be enrolled in the study. Total duration of study is two years.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with confirmed ACL or PCL injury who are planned for ACL or PCL resonstruction through arthroscopy surgery.
排除标准
- •Patients with a disease entity or condition that could hinder healing and create unacceptable risk of fixation failure or complications such as known active cancer neuromuscular disorder etc.
- •Patients with inadequate tissue coverage of the operative site.
- •Patients with history of effected knee arthroscopy surgery at the same site.
- •Patients with history of metal allergies.
- •Patients with documented mental disorders.
- •Patients who are incarcerated or have pending incarceration.
- •Patients with associated fractures which may interfere the rehabilitation and timely surgical fixation.
研究者
Dr Mohd Aslam
Auxein Medical Pvt Ltd
研究点 (2)
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